The invention relates generally to transcutaneous electrical neuro-stimulation (TENS) units and this invention particularly relates to a miniaturized wireless TENS unit capable of being pre-programmed to achieve a variety of waveforms, with or without the use of a remote controller means, each with unique features capable of masking pain or promoting functional restoration in a user""s body.
TENS devices have been traditionally prescribed in the medical industry for chronic pain. While patients experiencing acute pain are prescribed anti-inflammatories and narcotic agents, the treatment of chronic pain, usually defined as unrelieved pain for at least 30 days, has usually been dealt with via TENS-related prescriptions. However, TENS devices have been shown to provide rapid and effective relief for acute pain without side effects or the possibility of addiction. TENS does not utilize anesthesia or narcosis. Patients remain awake, alert and functional, and retain the protective qualities of increased pain perception.
TENS is commonly used for acute pain management by physical therapists in comprehensive rehabilitation programs in conjunction with other treatments. TENS devices are usually large as well as being complex, expensive and require lead wires running to each electrode, making them difficult for use at home, at work or at play.
Consequently there is a need in the art for a miniaturized, wireless TENS device that can be utilized by the patient without the embarrassment of unsightly wires protruding through clothing, and that can be placed on a variety of sites on the patient""s body, virtually unseen, and which can be controlled by a controller means to transmit pulses at different intensities and frequencies adaptable to the patient""s particular physical malady.
Previous attempts have been made to design improved electro-therapy devices, certain features of which are generally described in U.S. Pat. No. 5,620,470 to Gliner et al.; U.S. Pat. No. 5,607,454 to Cameron et al.; U.S. Pat. No. 5,601,612 to Gliner et al.; U.S. Pat. No. 5,593,427 to Gliner et al.; U.S. Pat. No. 5,584,863 to Rauch et al.; U.S. Pat. No. 5,578,060 to Pohl et al.; U.S. Pat. No. 5,573,552 to Hansjurgens; U.S. Pat. No. 5,549,656 to Reiss; U.S. Pat. No. 5,514,165 to Malaugh et al.; U.S. Pat. No. 5,476,481 to Schxc3x6ndorf; U.S. Pat. No. 5,387,231 to Sporer,; U.S. Pat. No. 5,397,338 to Grey et al.,; U.S. Pat. No. 5,374,283 to Flick,; U.S. Pat. No. 5,354,320 to Schaldach et al.; U.S. Pat. No. 5,304,207 to Stromer; U.S. Pat. No. 5,183,041 to Toriu et al.; U.S. Pat. No. 4,989,605 to Rossen; U.S. Pat. No. 4,759,368 to Spanton et al.; U.S. Pat. No. 4,699,143 to Dufresne et al.; and U.S. Pat. No. 4,398,545 to Wilson, all of which are incorporated herein by reference. However, none of these references, either alone or in combination with others, describes a miniature, wireless transcutaneous neuro stimulation device with a remote controlled configuration that has pre-programmable waveform modes and includes a unique detachable electrode-battery assembly. What is needed is a miniature, wireless TENS-related device that can easily be programmed by the user, with or without the use of a remote controller, to provide a variety of waveforms at various programmable intensities to a number of pain sites on the user""s body, and which can be easily adaptable for use with splints, braces and bandages. The present invention satisfies this need.
Generally, the present invention provides a miniature wireless transcutaneous electrical neuro or muscular-stimulation unit including a housing; a plurality of electrodes attached to the housing; an electronics module located within the housing and comprising an electrical circuit which provides a biphasic or monophasic sequence of pulses to the electrodes, wherein the sequence of pulses form a plurality of pre-programmable waveforms available for specific clinical needs; means to restrict the waveforms available to those appropriate for the electrode and treatment through a series of one or more protrusions within the housing, wherein the protrusions interface with the electronics module to determine the waveform to be used; means for allowing a user to select and control specific waveforms and intensities of the waveforms; means to identify the specific waveform chosen, its intensity and its duration; and means for supplying power to the electronics module wherein the means for supplying power is integrated with the electrodes in one assembly.
In an alternate embodiment the means for supplying power to the electronics module is a plurality of batteries.
An alternate embodiment of the present invention provides that the batteries are replaceable or rechargeable.
In an alternate version, the identifying means is an LCD digital readout display.
In an alternate embodiment, the means for allowing the user to select and control specific waveforms and intensities of waveforms is through a series of input devices controlling an LCD digital readout display which allows the user to vary the intensity of the waveforms.
In an alternate form, the means for allowing the user to select and control specific waveforms and intensities of waveforms comprises a removable tether having a first and second end wherein the first end is affixed to the electrode-battery assembly and the second end is affixed to the miniature wireless transcutaneous electrical neuro or muscular-stimulation unit.
In an alternate embodiment, the electrodes are disposable.
An alternate embodiment of the present invention provides that the electronics module be disposable.
In an alternate embodiment, the electronics module is detachable and is able to be snapped into and out of each miniature wireless transcutaneous electrical neuro or muscular-stimulation unit.
In an alternate form, the plurality of electrodes have varying shapes and sizes and can be affixed directly to a site or other area requiring electrical neuro or muscular-stimulation anywhere on the user""s body, the electrodes are positioned at a specified distance from the electronics module wherein the electrodes are swivel or fixed electrodes which allow for optimal placement of the electrodes at the pain site or the area requiring electrical neuro or muscular-stimulation.
In an alternate embodiment, the plurality of waveforms are comprised of but not limited to, a conventional-low mode and a conventional-high mode, a modulation-low mode and a modulation-high mode, an acupuncture-like low mode and an acupuncture-like high mode, a microcurrent mode, a burst mode and a cycling mode wherein the conventional-low mode supplies to the plurality of electrodes biphasic or monophasic pulses of about 0-60 milliamperes at a frequency of about 100 Hz having a pulse width of about 75 microseconds, the conventional-high mode supplies to the electrodes biphasic or monophasic pulses of about 0-100 milliamperes at a frequency of about 100 Hz having a pulse width of about 125 microseconds, the modulation-low mode supplies to the electrodes biphasic or monophasic pulses of about 0-60 milliamperes at a frequency of about 50-100 Hz having a pulse width of about 75-100 microseconds, the modulation-high mode supplies to the electrodes biphasic or monophasic pulses of about 0-100 milliamperes at a frequency of about 75-100 Hz having a pulse width of about 100-125 microseconds, the acupuncture-like low mode supplies to the plurality of electrodes biphasic pulses of about 0-60 milliamperes at a frequency of about 1 Hz having a pulse width of about 75 microseconds, the acupuncture-like high mode supplies to the electrodes biphasic pulses of about 0-100 milliamperes at a frequency of about 2 Hz having a pulse width of about 125 microseconds, the microcurrent mode supplies to the plurality of electrodes biphasic pulse of about 0-100 microamperes at a frequency of about 0.3-100 Hz, the burst mode supplies to the plurality of electrodes biphasic or monophasic pulses of about 0-100 milliamperes at a frequency of about 100 Hz having a pulse width of about 75 microseconds for a duration of three seconds on and three seconds off, and the cycling mode allows the user to program two or more modes into an individualized program.
In an alternate form, the plurality of waveforms are comprised of but not limited to, three unique muscle stimulation modes, a conventional mode, a modulation mode and three alternative cycling modes, wherein the first muscle stimulation mode supplies to the plurality of electrodes biphasic or monophasic pulses typically of about 0-100 milliamperes at a frequency of about 45 Hz at a pulse width of about 300 microseconds for approximately 5 minutes on and 5 minutes off, wherein the second muscle stimulation mode supplies to the plurality of electrodes biphasic or monophasic pulses typically of about 0-100 milliamperes at a frequency of about 45 Hz at a pulse width of about 300 microseconds for approximately 10 minutes on and 10 minutes off, the third muscle stimulation mode supplies to the plurality of electrodes biphasic or monophasic pulses typically of about 0-100 milliamperes at a frequency of about 45 Hz at a pulse width of about 300 microseconds for approximately 10 minutes on and 50 minutes off, the conventional mode supplies to the plurality of electrodes biphasic or monophasic pulses typically of about 0-100 milliamperes at a frequency of about 125 Hz at a pulse width of about 125 microseconds, the modulation mode supplies to the plurality of electrodes biphasic or monophasic pulses typically of about 0-100 milliamperes at a frequency of about 75-100 Hz at a pulse width of about 100-125 microseconds, the first alternative cycling mode supplies to the plurality of electrodes a sequence of biphasic or monophasic pulses comprised of the modulation mode for about 3 minutes followed by the first muscle stimulation mode for about 9 minutes, followed by the modulation for about 3 minutes, the second alternative cycling mode supplies to the plurality of electrodes a sequence of biphasic or monophasic pulses comprised of the modulation mode for about 3 minutes followed by the first muscle stimulation mode for about 9 minutes, followed by the modulation mode for about 3 minutes, and the third alternative cycling mode supplies to the plurality of electrodes a sequence of biphasic or monophasic pulses comprised of the modulation mode for about 3 minutes followed by the third muscle stimulation mode for about 9 minutes, followed by the modulation mode for about 3 minutes.
In an alternate embodiment of the present invention, an electrode-battery assembly is used in a miniature wireless transcutaneous electrical neuro or muscular-stimulation unit comprising a plurality of electrodes each having an internal and external side, a plurality of batteries each having a positive and negative pole, a flexible non-conductive carrier with a hydrogel which carries current to a pain site or other area on a user""s body via the electrodes, conductive film comprised of three current carrier runners wherein two of the runners are in direct contact with each of the positive and negative poles of the battery and a third said runner is in direct contact with the hydrogel, and a mechanical battery clip which secures the runners to the positive and negative battery poles.
In an alternate form, the electrode-battery assembly is disposable and can be replaced upon depletion of the battery.
In an alternate embodiment, the conductive film of the electrode-battery assembly is comprised of a silver alloy film or some other flexible low impedance material.
In another form, the external side of the electrode is covered by a molded cover comprised of a cosmetically appealing molded foam or elastomer.
In an alternate embodiment, a method of relieving acute or chronic body pain or muscle dysfunction requiring electrical neuro or muscular-stimulation on a user""s body using the miniature wireless transcutaneous electrical neuro or muscular-stimulation device described herein comprises the steps of affixing the plurality of disposable electrodes to a treatment site or other area requiring electrical neuro or muscular-stimulation on a user""s body, applying biphasic or monophasic sequence of pulses to the electrodes via an electrical circuit, providing a means for the user to select and control the plurality of waveforms and intensity of waveforms, providing a means for the user to identify the waveform, its intensity and its duration, and providing a means for supplying power to the electronics module wherein the means for supplying power is integrated with the electrodes in one detachable assembly.
In an alternate form, the miniature wireless transcutaneous electrical neuro or muscular-stimulation unit further comprises a transmitting device which includes a time function, a carrier signal capable of sending in a digital format, a means of identifying individual receivers, a synchronizing pulse, a means for setting the waveform mode, the intensity and the time duration, individually, of multiple remote electrode assemblies, a controller means capable of being worn on a comfortable site on the user""s body wherein the controller means sends transmission signals to the miniature wireless transcutaneous electrical neuro-stimulation unit by a communication means, and the electronics module further comprises a receiver capable of receiving and decoding signals from the transmitting device.
An alternate embodiment provides that the communication means is achieved by a capacitive coupling comprised of a plurality of conductive plates or transducers placed near the surface of the user""s skin wherein one of the conductive plates or transducers resides in the controller means and the other conductive plate or transducer resides in the miniature wireless transcutaneous electrical neuro or muscular-stimulation unit, using the user""s body as a conductive medium to transmit the transmission signals.
In an alternate form of the present invention, the controller means transmits signals between 20-500 kHz from the controller means through the user""s body to the transcutaneous electrical neuro-stimulation unit.
In an alternate embodiment, the communication means is achieved by over-the-air RF transmission comprised of a plurality of antennas with transmission signals between 40 kHz to 915 MHz.
In an alternate form, the transmission signals are synchronized to the miniature wireless transcutaneous electrical neuro or muscular-stimulation unit""s monophasic or biphasic sequence of pulses to avoid interference of transmission signals with monophasic or biphasic sequence of pulses.
An alternate embodiment of the present invention provides for a means of synchronizing the electrodes such that their polarities are 180 degrees out of phase causing electrons to be exchanged between the electrodes.
In an alternate form, the controller means is worn on the user""s wrist.
In an alternate version of the present invention, the electronic module is a remote module with display means which allows the remote module to be identified by the controller means and which sets a software address thereby allowing the controller means to send transmissions signals to an identifiable remote module.
In an alternate embodiment, the miniaturized wireless transcutaneous electrical neuro or muscular-stimulation unit further comprises a plurality of post-surgical incisional electrodes, a standard splint, bandage, manufactured brace, or cast comprised of multiple layers wherein the splint, bandage, brace or cast is embedded with non-visible wires or flex-circuit material, the electrodes are embedded in the splint, bandage, brace, or cast, the wires or flex-circuit material provide for connection between the plurality of electrodes and disposable miniaturized transcutaneous electrical neuro-or muscular stimulation unit, and the plurality of electrodes are arranged in a grid-like manner to allow for programming of a specific firing order which can provide for greater therapeutic effect to the pain site.
In another embodiment, the miniature wireless transcutaneous electrical neuro or muscular-stimulation unit further comprises a gauze pad having an antibacterial agent positioned substantially adjacent to and substantially beneath said electronics module, and a plurality of adhesive strips in which the plurality of electrodes are embedded.
In an alternate form, the plurality of waveforms are comprised of but not limited to, a conventional of modulation low mode and a microcurrent mode wherein the conventional-low mode or the modulation-low mode supplies to the plurality of electrodes biphasic or monophasic pulses of about 0-30 milliamperes at a frequency of about 80-100 Hz having a pulse width of about 75 microseconds and the micro current mode supplies to the plurality of electrodes the biphasic pulse of about 0.3-100 Hz.